Cytosar-U Side Effects
Generic Name: cytarabine
Note: This document contains side effect information about cytarabine. Some of the dosage forms listed on this page may not apply to the brand name Cytosar-U.
For the Consumer
Applies to cytarabine: parenteral conventional cytarabine injection, parenteral conventional cytarabine powder for injection, parenteral liposomal cytarabine injection
Side effects include:
IV, sub-Q, or IM administration of conventional cytarabine (the active ingredient contained in Cytosar-U) Myelosuppression, anorexia, nausea, vomiting, diarrhea, oral and anal inflammation or ulceration, hepatic dysfunction, fever, rash, thrombophlebitis, bleeding (all sites).
Intrathecal administration of conventional cytarabine: Nausea, vomiting, fever, transient headaches.
Intrathecal administration of liposomal cytarabine: Chemical arachnoiditis (neck rigidity, neck pain, meningism, nausea, vomiting, headache, fever, back pain, and/or CSF pleocytosis), asthenia, pain, confusion, somnolence.
For Healthcare Professionals
Applies to cytarabine: injectable powder for injection, injectable solution
Very common (10% or more): Hemorrhagic conjunctivitis, corneal disorder
Common (1% to 10%): Photophobia, burning, visual disturbance, increased lacrimation, keratitis
Uncommon (0.1% to 1%): Conjunctivitis
Frequency not reported: Blindness[Ref]
Very common (10% or more): Somnolence
Common (1% to 10%): Decreased level of consciousness, dysarthria, nystagmus
Frequency not reported: Dizziness, neurotoxicity rash, coma, convulsion, peripheral sensory neuropathy, ataxia, tremor, coma, convulsions[Ref]
Uncommon (0.1% to 1%): Chest pain
Very rare (less than 0.01%): Arrhythmia
Common (1% to 10%): Bleeding (all sites), thrombophlebitis
Very common (10% or more): Sepsis, infection
Frequency not reported: Viral, bacterial, fungal, parasitic, or saprophytic infections, in any location in the body (sometimes fatal)[Ref]
Uncommon (0.1% to 1%): Injection site cellulitis, injection site thrombophlebitis
Frequency not reported: Injection site pain, injection site inflammation, injection site irritation, injection site sepsis[Ref]
Very common (10% or more): Cytarabine (the active ingredient contained in Cytosar-U) syndrome (e.g., fever, myalgia, bone pain, occasionally chest pain, exanthema, maculopapular rash, conjunctivitis, nausea, malaise)
Uncommon (0.1% to 1%): Myalgia, joint pain[Ref]
Common (1% to 10%): Anorexia, hyperuricemia[Ref]
Frequency not reported: Personality change, confusion[Ref]
Uncommon (0.1% to 1%): Urinary retention
Very common (10% or more): Hepatic function abnormal
Common (1% to 10%): Liver enzymes increased
Uncommon (0.1% to 1%): Jaundice
Uncommon (0.1% to 1%): Shortness of breath[Ref]
Very common (10% or more): Pyrexia[Ref]
Uncommon (0.1% to 1%): Renal dysfunction[Ref]
Very common (10% or more): Alopecia, rash
Very rare (less than 0.01%): Neutrophilic eccrine hidradenitis
Frequency not reported: Skin bleeding[Ref]
Common (1% to 10%): Necrotizing colitis
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Cytarabine (cytarabine)." Hospira Inc, Lake Forest, IL.
Some side effects may not be reported. You may report them to the FDA.